BY KURT SAMSON
The National Cancer Institute has awarded the first research grants to community-based researchers under the new National Community Oncology Research Program (NCORP), a five-year, $93 million initiative.
The plan was initially proposed in 2012, and the NCI’s Board of Scientific Advisors approved creation of the program in June 2013 with the aim of bringing state-of-the art cancer prevention, control, treatment, and imaging clinical trials; and cancer care delivery research and to local communities, and help eliminate disparities in trials among minorities.
Earlier this month NCORP awarded 53 new five-year grants to investigators to conduct multi-site clinical trials and cancer-care delivery studies in communities across the country through a national network of researchers, providers, academic institutions, and other organizations that care for diverse populations in community-based cancer care. Grants were awarded to the top 40 institutions that had a demonstrated track record of meeting or exceeding the study goals along with exhibiting leadership and commitment in communities.
The program replaces and builds on two previous NCI community-based clinical research programs: the NCO Community Clinical Oncology Program (CCOP) and the NCI Community Cancer Centers Program (NCCCP). Ongoing trials under these programs will be integrated into NCORP to ensure completion, and CCOP sites that were not included as NCORP sites will receive support to allow patients to complete their studies and receive appropriate follow-up care.
Research will focus on a range of diverse and multi-level factors, including social outreach, financing systems, processes, technology, and other factors that affect access and quality of care, NCORP Director Worta McCaskill-Stevens, MD, said in announcing the awards.
NCORP will allow NCI to take advantage of recent advances in understanding cancer and bring this new knowledge into clinical trials at the community level, she said, adding that the program will identify and evaluate critically needed interventions that reduce cancer risk and incidence, enhance cancer patients’ quality of life, and increase access to clinical trials and care delivery in minority, rural, and other underserved patient populations.
The 53 awards fall into three categories:
- Seven sites will serve as hubs for the NCORP network, to design and conduct multicenter clinical trials and cancer care delivery research, as well as provide overall administration, data management, scientific leadership, and regulatory compliance.
- An additional 34 community sites have received funding to recruit clinical trial participants for program-funded studies, as well as for the NCI National Clinical Trials Network (NCTN) treatment and imaging trials, quality of life studies, and cancer care delivery research.
- Twelve sites have been chosen to also recruit clinical trial participants, with a mandate to include at least 30 percent of subjects from racial/ethnic minorities or rural residents.
According to the NCI, “ongoing clinical trials will be seamlessly incorporated into NCORP and continue to completion to achieve continuity of care for patients.”
‘Big Deal, Changes the Funding Structure’
“This has been a long time coming,” said oncologist Michael A. Thompson, MD, PhD, Medical Director of Early Cancer Research at Aurora Cancer Care, in Racine, Wisconsin. “I think that because there is more access to care in other parts of the country, especially in western states, NCI may be beefing up its support for clinical trials in the Midwest.”
Aurora will receive $3.8 million from NCORP over five years to improve cancer research and expand patient access to clinical trials in Wisconsin. National accrual of adult cancer patients into clinical trials is less than five percent, but the center’s wide reach -- Aurora offers services at sites in more than 90 communities throughout eastern Wisconsin and northern Illinois, he said -- will allow increased trial access for approximately 60 percent of Wisconsin’s population.
Thompson noted that many of the ongoing clinical trials that were previously under CCOP and NCCCP will continue, but the shift to NCORP will add necessary infrastructure and help with more dedicated delivery research.
“I think we have demonstrated a proven track record of success, and those research institutes that have not received awards will now have a harder time, but we will have NCI’s support through NCORP. This is a big deal because it changes the funding structure, and between 80 and 85 percent of cancer patients are seen at community centers.”
Aurora works with a number of other centers in the area, including Milwaukee, which Dr. Thompson says has the highest rate of racial segregation of any state. Empowering community centers through NCORP should greatly increase access and recruitment on minorities, he said.
Reaching Minorities in the South
As the only NCORP Minority/Underserved Community Site in Georgia, and one of just 12 selected nationally, Georgia Regents University’s Cancer Center, in Augusta, has been involved for a decade in the CCOP consortium, providing cancer care and recruiting minority patients from underserved populations, said Samir N. Khleif, MD, Director of the Cancer Center and Professor of Biochemistry and Molecular Biology.
“I think there are many reasons we were chosen,” he said in an interview. “We are well placed to help recruit minority patients for clinical trials and have an excellent infrastructure in place, as well as expertise in different areas. Not only do we serve many low-income African-American and Hispanic patients but we are part of a really good network on cancer centers in the state, including Morehouse College, Georgia Southern University, and the University Cancer and Blood Center, in Athens. These are very good cancer centers with a real interest in treatment disparities.”
He said GRU will use the funds to increase awareness and participation in NCI-sponsored clinical trials, especially cancer care delivery research throughout Georgia. It will also contribute to the design and translation of NCORP’s research agenda among minority and underserved populations.
“Georgia has a high rate of minority cancer patients,” he said. “There are about four million patients in Atlanta alone, and 90 percent of them are minorities. This award will help us build upon more than a decade of experience serving as a Minority-Based CCOP, which NCORP is replacing. This grant is in perfect alignment with our shared commitment to serve all Georgians with the best possible cancer care.”
He noted that the incidence of prostate cancer, for example, is two times higher in African-American men and that they have three times greater mortality than their Caucasian counterparts. Similarly, triple-negative breast cancer incidence and mortality is also higher.
“Although there are multiple clinical trials, African-American subjects represent only about eight percent of the overall study population,” he said. “African-Americans are severely underrepresented in most clinical trials, but I think we can really answer a lot of questions in this population with greater outreach and recruitment efforts in our state.”
‘Affirmation and Recognition’
In South Carolina, the Greenville Health System Cancer Institute was another recipient.
“Transportation, technology, finances, and pre-existing chronic diseases are all examples of factors that contribute to poor health outcomes,” the Medical Director, Larry Gluck, MD, said in a statement. “This grant is an affirmation and recognition of our ongoing efforts to find and develop innovative ways to improve all aspects of cancer care delivery. It is also a vote of confidence in our ability to take research to the next level.”
The center has participated in NCI-sponsored research since 1988 and has had one of the highest rates of patient recruitment, with more than 270 clinical trials each year.
Gary Goodman, MD, a senior investigator at the Swedish Cancer Institute-Medical Oncology, in Seattle, said that the NCORP grant will help him and his colleagues in the Northwest continue to accrue patients into clinical trials, something they have been doing successfully for more than 30 years. He holds a joint membership with the Fred Hutchinson Cancer Research Center.
The Swedish Cancer Institute is the largest nonprofit health-care provider in the Seattle area and one of the largest cancer treatment centers in the Northwest. The Institute is affiliated with cancer centers in Oregon, Alaska, and Idaho, and also works to accrue patients with oncologists in personal practice and at small hospitals, in addition to Providence Portland Medical Center and St. Luke’s Mountain States Tumor Institute, in Boise, Idaho.
Goodman said that when the NCI first announced the merger of its earlier programs into NCORP and began soliciting grant applications, he was unsure of his institution’s ability to qualify. “Because we are non-academic, we were initially ineligible to apply for NCORP funding. Fortunately, we have a long-standing relationship with NCI, and accrued the largest number of patients for clinical trials involved in NCI’s SWOG [formerly the Southwest Oncology Group] partnership.
“We currently have more than 30 affiliates, so we are very pleased and hope to expand cancer treatment and recruitment within the communities we all serve and are hoping more hospitals will join us,” he said. The center recruits some 400 cancer patients into clinical trials each year, more than most of the other individual grant recipients.
A list of all 53 grant recipients can be viewed at: http://ncorp.cancer.gov/about/sites.html#research-bases